Menu
Recruiting NCT06401616

Can Patients With Atrial Fibrillation Safely Discontinue Anticoagulant Therapy After Cardiac Surgery? (ATLAAC)

Phase IV Interventional Atrial Fibrillation Left Atrial Appendage Absent Anticoagulant Adverse Reaction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: OAC will be discontinued for the duration of the trial.
Who it may be relevant to
Registry conditions: Atrial Fibrillation, Left Atrial Appendage Absent, Anticoagulant Adverse Reaction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Anticoagulant Therapy in Patients With Atrial Fibrillation After Surgical Left Atrial Appendage Closure: a Randomized Non-inferiority Trial (The ATLAAC Trial)

Overview

Left atrial appendage (LAA) closure has become a frequent addition to oral anticoagulation in patients with atrial fibrillation who undergo cardiac surgery. The procedure significantly reduces the risk of stroke and systemic embolism, which may render anticoagulation unnecessary or even harmful when considering the associated increased risk of bleeding. A clinical trial to address the need for anticoagulation after LAA closure is needed. The ATLAAC trial will enroll 1220 patients with atrial fibrillation who have previously undergone surgical LAA closure. Patients will undergo a cardiac CT-scan to determine if LAA closure was successful and patients with successful closure will be randomized to continue or discontinue anticoagulation. The trial will assess the risk of ischemic stroke, peripheral arterial embolism, and major bleeding during the randomized intervention

Interventions

  • Drug OAC will be discontinued for the duration of the trial
    Discontinuation of warfarin, dabigatran, rivaroxaban, apixaban or edoxaban

Primary outcome measures

  • Number of participants with ischemic strokes, peripheral arterial embolisms and major bleedings [Time frame: After 128 primary outcome events (approx 4 years)]
Secondary outcome measures (12)
  • Severity of stroke [Time frame: After 128 primary outcome events (approx 4 years)]
  • Occurence of transient ischemic attacks [Time frame: After 128 primary outcome events (approx 4 years)]
  • Occurence of all-cause stroke [Time frame: After 128 primary outcome events (approx 4 years)]
  • Rate of all-cause mortality [Time frame: After 128 primary outcome events (approx 4 years)]
  • Rate of cardiovascular mortality [Time frame: After 128 primary outcome events (approx 4 years)]
  • Occurence of minor bleeding [Time frame: After 128 primary outcome events (approx 4 years)]
  • Number of participants who receive blood transfusion [Time frame: After 128 primary outcome events (approx 4 years)]
  • Occurence of myocardial infarction [Time frame: After 128 primary outcome events (approx 4 years)]
  • Occurence of deep venous thrombosis [Time frame: After 128 primary outcome events (approx 4 years)]
  • Occurence of pulmonary embolism [Time frame: After 128 primary outcome events (approx 4 years)]
  • Health-related Quality of Life (HRQOL) [Time frame: Baseline (day 0) and 1 and 2 years after inclusion]
  • Patient-reported satisfaction with overall medical treatment [Time frame: Baseline (day 0) and 1 and 2 years after inclusion]

Eligibility criteria

Inclusion criteria

  • Age > 18 years
  • Previously undergone any type of cardiac surgical procedure including any type of surgical LAA closure (use of any of the following techniques; amputation and suture closure, stapler closure, non-amputating suture closure or closure with an approved surgical occlusion device (e.g. AtriClip)) according to the NationalPatient Register (NPR), the Danish Heart Registry (DHR) or the Western Danish Heart Registry (WDHR) from January 1st 2010 til 3 months prior to inclusion in the project.
  • Documented history of paroxysmal, persistent, or permanent atrial fibrillation or atrial flutter according to the electronic patient record
  • Informed consent

Exclusion criteria

  • Not receiving OAC (warfarin/DOAC)
  • Patient specific conditions requiring OAC (e.g.mechanical valve, previous pulmonary embolism)
  • Renal impairment (estimated glomerular filtration rate < 30)
  • Allergy to contrast media
  • Pregnancy or breastfeeding

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Denmark · 6 centers
  • Rigshospitalet — Copenhagen
  • Gentofte Hospital — Gentofte Municipality
  • Regionshospital Gødstrup — Herning
  • Aalborg university hospital — Aalborg
  • Århus Universitetshospital — Aarhus
  • Odense University Hospital — Odense

Publications

  • Gosvig K, Goller J, Hansson NH, Brandes A, Modrau I, Rasmussen LF, Eskesen K, Jensen AKG, Belley-Cote E, Whitlock R, Riber LPS. Rationale and design of the anticoagulant therapy after left atrial appendage closure (ATLAAC) trial. Am Heart J. 2025 Sep;287:86-93. doi: 10.1016/j.ahj.2025.04.015. Epub 2025 Apr 15. PMID 40246048

Identifiers

NCT: NCT06401616 · 2022-502986-92-00 · 2022-502986-92-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗